Boddingtons Plastics Ltd Wheelbarrow Park Estate Pattenden Lane Tonbridge United Kingdom Recalls

FDAMar 10, 2020FL• Matthew 7:25 Inc dba Thrive Pharmacy

Buprenorphine Black Cherry Troche (Thrive Pharmacy) – subpotent drug (2020)

Subpotent Drug

Class II

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Moderate

FDAMar 10, 2020FL• Matthew 7:25 Inc dba Thrive Pharmacy

Buprexone Banana Troche (Thrive Pharmacy) – subpotent drug (2020)

Subpotent Drug

FDAMar 10, 2020FL• Matthew 7:25 Inc dba Thrive Pharmacy

Theophylline Extended-Release (Nostrum) – Labeling Errors (2020)

CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.

FDAMar 6, 2020MO, TN• Nostrum Laboratories Inc

Baxter Healthcare Corporation: GEM Microvascular Anastomotic Coupler Devices - Product U...

The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device

FDAMar 5, 2020Nationwide• Baxter Healthcare Corporation

Natus Neurology DBA Excel Tech., Ltd. (XLTEK): natus newborn care Olympic Brainz Monitor, REF OBM00002. ...

The OBM system functional test (impedance and noise) was not carried out on the affected items prior to release to the customer. The manufacturer cannot attest to the system functionality of the affected items.

FDAMar 5, 2020Nationwide• Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation standalone software treatment planning system,...

Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will be more restricted in the wedged direction than the maximum field opening without a wedge. Delivering a larger field opening with a virtual wedge will not result in a wedged field shape over the entire field. Instead, a high dose plateau region will be the result at the toe side of the field beyond the recommended field size.

FDAMar 4, 2020Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

Peppermint Lip Moisturizer (Yusef) – Ingredient Overdose (2020)

Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.

FDAMar 3, 2020Nationwide• Yusef Manufacturing Laboratories, LLC

Merits Holdings Co. dba Merits Health Products, Inc.: Merits E604 Pilot Navigator Stairlift - Product Usage: To...

Pinion gear may disengage from track allowing lift to slip or jolt.

FDAMar 2, 2020Nationwide• Merits Holdings Co. dba Merits Health Products, Inc.

Organic Lentil Trio (Global Juices & Fruits) – gluten contamination (2020)

Gluten-Free lentils product tested positive for gluten and some pouches were found to contain barley, wheat, and possibly other gluten-containing grains.

FDAMar 2, 2020IL, IN, NY +1 more• Global Juices & Fruits LLC

Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical: Nexus Universal with OptiBond Universal, Universal Adhesi...

An issue within production process used to package trial kits let to the inclusion of the incorrect bonding agent for the kit. Use of the incorrect bonding agent may lead to increased risk of bond failures.

FDAFeb 25, 2020Nationwide• Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical

Chia/Flax Boost Supplement (Organic By Nature) – unapproved herbicide (2020)

Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop

Zoledronic Acid Injection (Breckenridge) – Impurity Specs (2020)

Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.

FDAFeb 24, 2020Nationwide• Breckenridge Pharmaceutical, Inc

Super Kids Superfood (Nested Naturals) – Unapproved Herbicide (2020)

Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop

L.O.V.E. Supermeal Original (Organic By Nature) – unapproved herbicide (2020)

Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop

Green Power (Springboard) - Unapproved Herbicide (2020)

Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop

Slim Natural Raw Meal (Erom) - Unapproved Herbicide (2020)

Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop

Daily Fiber Blend (Organic By Nature) – Unapproved Herbicide (2020)

Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop

Creamy Vanilla Protein (Alkamind) – Unapproved Herbicide (2020)

Firm was notified by supplier that Organic Ground Flaxseed powder was under recall by manufacturer due to unapproved herbicide - Haloxyfop